NICE has released new patient decision aids so that women can work alongside their clinicians to pick the best course of treatment for stress urinary incontinence or pelvic organ prolapse.
The decision aids detail every surgical option NICE recommends women should be offered, using the best available evidence. They also make clear what non-surgical options NICE recommends as alternatives.
The benefits and risks of each type of treatment are laid out to ensure every woman is fully informed. Where the evidence is limited, this is also highlighted.
NICE, however, have highlighted that in cases where it is agreed to use surgical mesh/tape, women must be fully informed of the risks which could include dyspareunia – painful sexual intercourse – pain and other problems.
Patients, clinical experts and professional bodies were involved in the development of the patient decision aids, which are endorsed by NHS England. The patient decision aid for surgery for stress urinary incontinence is also endorsed by the British Association of Urological Surgeons, the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology.
Providing patient decision aids supports shared decision-making, a two-way process designed to help each woman to think about what her priorities are and to make a choice that is consistent with these.
Decision-making aids will be published for:
- Surgery for stress urinary incontinence
- Surgery for vaginal vault prolapse
- Surgery for uterine prolapse
There are a number of non-surgical options to treat both urinary incontinence and pelvic organ prolapse which should be considered before surgery.
The non-surgical options for urinary incontinence include:
- Lifestyle interventions, including caffeine reduction
- Physical therapies, such as pelvic floor muscle training
- Behavioural therapies, such as bladder training
Non-surgical options for pelvic organ prolapse include:
- Lifestyle modification, such as losing weight if the woman is overweight and minimising heavy lifting
- Topical oestrogen
- Pelvic floor muscle training
- Pessary management
If non-surgical options haven’t worked or if the woman decides against them, she may wish to discuss a surgical option with her clinician. If alternative surgical procedures are not suitable for or acceptable to the woman to manage stress urinary incontinence, clinicians should consider intramural bulking agents.
There are a number of procedures recommended by NICE, including mesh procedures. While there is evidence of benefit, there is limited evidence on possible long-term harms of all surgical options. In particular, the true prevalence of long-term complications following surgery with mesh is unknown.
If a woman’s chosen intervention is not available from the consulting surgeon, she should be referred to an alternative surgeon, the guideline recommends.
A follow-up appointment should be offered within six months to all women who have had urinary incontinence or prolapse surgery.
The guideline also recommends how complications associated with surgical mesh/tape surgery should be assessed and managed.
Consultants at centres specialising in the diagnosis and management of surgical mesh/tape-related complications should develop an individualised investigation plan for each woman with suspected or confirmed mesh-related complications.
Complications related to the device should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and details of the complications should be collected in a national database.
There are a number of recommendations included in the guideline for surgical mesh/tape-related complications including:
- Referring women with a confirmed surgical mesh/tape-related complication, or unexplained symptoms after a surgical mesh/tape procedure, to a consultant at a regional centre specialising in the diagnosis and management of surgical mesh/tape-related complications.
A national database should be set up to record all procedures involving the use of surgical mesh/tape in operations for stress urinary incontinence or pelvic organ prolapse to help with future decision making.
In July 2018 a national ‘pause’ was announced by the government on the use by the NHS of surgical mesh/tape to treat stress urinary incontinence and for urogynaecological prolapse where the mesh is inserted through the vaginal wall. This ‘pause’ takes the form of a high vigilance restriction period during which certain conditions apply.
This will remain in place until a number of conditions are met including:
- Registering all operations and any complications on a national database
- Surgery being performed by specialist surgeons based at specialist centres
At the time of publication of this updated NICE guideline, the high vigilance restriction was still in place and, until it ends, professionals should continue to follow its requirements.
Baroness Julia Cumberlege is leading the Independent Medicines and Medical Devices Safety Review which was initiated by the Department of Health and Social Care in February 2018. The review is looking into the use of abdominal and vaginal pelvic mesh procedures. The review is still in progress and at present, there is no date set for publication.
NICE's clinical guideline is completely independent of the Cumberlege review and is published now within our normal timeframe. This is the first national guideline to comprehensively cover the assessment and conservative treatment of pelvic organ prolapse.
Dr Paul Chrisp, director for the centre for guidelines at NICE, said: “The patient decision-making aids developed by NICE in association with patients, clinicians and professional bodies will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure.
“It will ensure each woman is able to decide, with the help of her clinician, which option is best for her. This might include the decision not to have surgery at all.
“Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can."